Statin Therapy in Patients With Early Stage ADPKD

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    200
  • sponsor
    University of Colorado, Denver
Updated on 26 January 2021
investigational drug
glomerular filtration rate
renal disease
pravastatin

Summary

This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.

Description

This is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with ADPKD by evaluating 1) kidney volume as measured by kidney magnetic resonance imaging (MRI); 2) renal blood flow as measured by kidney magnetic resonance angiography (MRA); 3) kidney function as assessed by Glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in ADPKD; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. These parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with ADPKD.

Details
Condition Polycystic Kidney, Autosomal Dominant, autosomal dominant polycystic kidney disease
Treatment Placebo, Pravastatin
Clinical Study IdentifierNCT03273413
SponsorUniversity of Colorado, Denver
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of ADPKD
Total kidney volume >500 mL
Estimated glomerular filtration rate (GFR) 60 mL/min/1.73m^2
Controlled blood pressure <140/80 mmHg

Exclusion Criteria

Uncontrolled hypertension
Diabetes mellitus
Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
Unstable angina
Coronary artery disease
Prior ischemic stroke
Other clinical indication for a statin
History of hospitalizations within the last 3 months
Hepatic impairment or liver function abnormalities
Secondary hypercholesterolemia or hypocholesterolemia
Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
Hypersensitivity to statins
Immunosuppressive therapy within the last year
Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
Hypersensitivity to iodine
Pregnant or breast feeding
Current tobacco use
Alcohol abuse or dependence
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